MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-01 for WALLFLEX DUODENAL M00565020 6502 manufactured by Boston Scientific Corporation.
[134748984]
(b)(4). The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[134748985]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex doudenal stent has been implanted to treat a malignant gastric outlet obstruction in the duodenum during a stent placement procedure performed on (b)(6) 2019. Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement. According to the complainant, during the procedure, the stent was fully deployed. However, after deployment the physician had concerns that the stent did not fully expand. Reportedly, the stent left implanted and the physician did not take any action to expand the stent. The stent was not removed and it was reported that the stent has since fully expanded. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00265 |
| MDR Report Key | 8297145 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-01 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-07 |
| Date Mfgr Received | 2019-01-07 |
| Device Manufacturer Date | 2018-09-26 |
| Date Added to Maude | 2019-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLFLEX DUODENAL |
| Generic Name | STENT,METALLIC,EXPANDABLE,DUODENAL |
| Product Code | MUM |
| Date Received | 2019-02-01 |
| Model Number | M00565020 |
| Catalog Number | 6502 |
| Lot Number | 0022708562 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |